Director, Quality Control

Quanterix is a company on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping researchers advance the science of precision health. Simoa® is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology.  To continue our growth, we are seeking a talented and highly motivated Director, Quality Control to join our growing organization located in Billerica, MA.   

This position will be part of our Quality & Regulatory team and is responsible for all Quality Control functions. The functions within Quality Control include incoming materials inspection and testing, functional performance testing for in-process components and kits, component and kit lot release and routine product stability monitoring. This position will be responsible for day-to-day operational execution, in a highly cross-functional environment, that drive high quality product, high levels of customer service and compliance. The ideal candidate will be an experienced, high-energy leader with knowledge in Lean, Value Stream or Six Sigma principles in addition to a depth of experience in fast-paced Quality Control testing environments.

What You’ll Do:

• Recruitment, training, performance management, and professional development of Quality Control Testing personnel
• Manage inspection and testing of incoming raw materials, including chemicals, biologicals and packaging and labeling materials
• Manage functional performance testing for in-process reagent components and finished goods release
• Manage testing and value assignment process for calibrators, controls, and panels
• Manage batch record auditing and lot release processes for all components and kits distributed by Quanterix
• Manage all necessary documentation (testing and inspection protocols and specifications, process documents, Certificates of Analysis) to create compliant Product Testing processes
• Manage routine product stability program
• Work with the Assay Development team to identify the critical vs. routine parts of the manufacturing process to identify areas where in-process testing might be required or beneficial
• Lead a gap analysis of the Quality related protocol/procedures for continuous improvement

What We’ll Expect From You:

• Bachelor’s Degree in Biology, Chemistry or related Life Sciences, Master’s Degree a plus
• 12 years’ experience in medical device or life science industry
• 7 years’ experience managing immunoassay Product Testing or Quality Control operations
• 7 years of experience leading and managing high performance teams in a Quality Control setting
• ASQ or comparable certification a plus
• Strong statistical knowledge and skills
• Experience with GMP- and ISO-certified manufacturing and Quality Control operations preferred
• Possess the ability to proactively adapt to rapid changes in business priorities and foster teamwork among employees to maintain high quality standards
• Excellent organizational, record keeping and communication skills
• Demonstrated ability to work well within cross-functional teams as a team player
• Possess an ability to learn and master complicated concepts quickly and comfortably
• Ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude
• Proven team and people leader and able to drive team building and individual professional development

Why You’ll Like Working For Us: 

Our Technology: Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com. 

Our Commitment to Employees: At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!   

Quanterix is committed to a Diverse and Inclusive workplace. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. 

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